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临床试验/NCT04672174
NCT04672174Enrolling By Invitation不适用

Cognitive Screening of Patients with Hearing Loss

University of Zurich2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
20
试验地点
2
主要终点
Questionnaire to assess effect of hearing loss on memory (DemTect)

研究概览

简要总结

Hearing loss and cognitive impairment both appear in elderly patients. The goal was to use a modified screening method added to already established cognitive tests to obtain a standardized test for detection of cognitive impairment in patients with hearing loss.

The aim of this study is to collect data with neuropsychological tests using questionnaires and to determine cognitive impairment in patients with hearing loss.

The collected data will be evaluated using SPSS 23. The corrected item-total correlation and item difficulty of the item DemTectEar will be assessed by item analysis / Cronbachs' Alpha. For further evaluation and comparisons two-sided t-tests with a level of significance 0.05 or Mann-Whitney-U-tests will be performed.

详细描述

Cognitive impairment and dementia are a growing health-care problem in our society. The prevalence of dementia is still estimated to grow drastically and reach over a 100 million world-wide by the year 2050. To address this problem there are numerous neuropsychological screening methods, for example the mini-mental state examination (MMSE) or the DemTect.

Another age-dependent problem is the increasing hearing impairment. Furthermore, studies have shown that hearing loss is associated with cognitive decline and may accelerate the process. Nevertheless, there is no specific cognitive screening method for patients with a sensory hearing loss.

This study aims to obtain a specifically modified version of the general DemTect called DemTectEar for patients with pre-existing hearing loss. Such a screening method would lead to earlier detection, earlier therapy and thereby to deceleration of cognitive decline.

Patient charts are screened to identify possible participants. They are contacted to participate in the study during regular clinical follow-up consultations or are contacted by phone or mail.

The investigators will explain to each participant the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits and any discomfort it may entail. Each participant will be informed that the participation in the study is voluntary and that he or she may withdraw from the study at any time and that withdrawal of consent will not affect his or her subsequent medical assistance and treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Age 50 - 90
  • Measurable hearing loss
  • Sufficient knowledge of german
  • Ability to consent

排除标准

  • Age < 50 or >90
  • No measurable hearing loss
  • Present or past alcohol or drug abuse
  • Clinically relevant depressive symptoms
  • lnability to consent

结局指标

主要结局

Questionnaire to assess effect of hearing loss on memory (DemTect)

时间窗: 2 years

Effect of hearing loss on memory

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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